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The FDA's timing couldn't seem stranger. In July, Florida senator Bob Graham introduced the Ecstasy Prevention Act of 2001, which would allocate more than $22 million to heightened law enforcement, a "Just Say No"- type media campaign, and the creation of a new Ecstasy drug test. The bill coincided with a two-day conference at the National Institutes of Health that summarily blasted MDMA.
"People who take a single, oral dose [of Ecstasy] run the risk of partial brain serotonin injury," Dr. George Ricaurte, a leading MDMA researcher at Johns Hopkins Medical Institutions, told the audience.
Federal law-enforcement officials have been busy, too. In October, the Drug Enforcement Agency seized 48,000 Ecstasy pills during Operation Triple X. Displaying no compassion for compassionate use, the DEA raided the Los Angeles Cannabis Resource Center a week later, confiscating the medical-marijuana outfit's computers, patient records, and pot plants. It was California's third such crackdown in a month. A serious blow had been dealt to medical-marijuana supporters. Or so it seemed.
A day after psilocybin was being doled out to patients in Arizona, the DEA gave final approval for two medical-marijuana studies, the first of several planned by the University of California's Center for Medicinal Cannabis Research. The center just got a DEA-issued certificate allowing it to obtain legal, government-grade pot from the National Institute on Drug Abuse (NIDA). And if the results look promising? "We may see some [reclassifying of marijuana] if there is reason to believe there are legitimate medical reasons," says Donald Thornhill, a DEA spokesman in San Diego.
The real source of these changing attitudes is the FDA. According to Dr. David E. Nichols, president of the Heffter Institute and a professor of pharmacology at Purdue University, the groundwork for much of the current research was laid in the mid '90s, when the FDA approved psychiatry professor Dr. Rick Strassman's studies with DMT, a potent hallucinogen, at the University of New Mexico. "There was a lot of dialogue in the FDA that there should be no different requirements with these drugs, which is the way the FDA should have always been operating," explains Nichols.
In a government bent on eradicating illegal drugs, the FDA may be the agency most immune to political pressures. It's made up of scientists whose mission is to help develop medicine, and they're open to the idea that any given compound is not entirely good or bad. Just listen to the words of Katherine Bonson, a pharmacologist who addressed an Ecstasy conference organized by the Lindesmith Center in February. Since her post at the FDA prevented her from discussing any particular drug, Bonson spoke of a "Drug X," in remarks now catalogued online (www.drugpolicy.org/ecstasy_conf). "It's unclear whether this alleged Drug X could actually be approved, because we don't have any data," said Bonson, who stressed that she was speaking as an independent scientist rather than as an FDA official. "That's the take-home message. We really need to see something. So if you give us data that makes it look like a good drug, we'll approve that drug."
If the FDA has been viewed by many as an agency guided by reason and not politics, its next of kinNIDAhas been held in less esteem. "I think of NIDA as science in the service of repression," says Doblin. "They want to know what's wrong with these drugs and how they can use the data to justify the drug war."
Proponents of medical MDMA accused NIDA of shutting them out of the July conference. "They didn't want anyone talking there that would diverge from the party line," says Dr. Charles Grob, director of child and adolescent psychiatry at Harbor-UCLA Medical Center, who headed up the first FDA-approved research with MDMA. That 1994 study was to have considered benefits for cancer patients. Preliminary research showed the drug was safe enough for more testing, Grob says, but FDA resistance effectively shelved the project.
Nearly a decade later, the party line still seemed to be that Ecstasy was unequivocally harmful. "Maybe this drug will be called 'despair' in the future," said chairman Jerry Frankenheim during the government conference's closing remarks.
So how did the scientists behind the new trials get past the gloomy prognostics? For starters, they were able to gather statistics showing MDMA was safe at the proposed doses and wouldn't cause the harm to memory feared by the government. A leading researcher in the field of Ecstasy and memory wrote a letter of support. And, perhaps most important, the protocol mimicked drug giant Pfizer's trials for the antidepressant Zoloft. All of that seem to sway the FDA, opening the door for research.
In the end, other agencies will have to follow the FDA's lead. "If the [MDMA study] has been approved through the proper channels, we really don't have a say in it," says the DEA's Agent Thornhill. Even NIDA, which Doblin says refused to provide psilocybin for the University of Arizona study, is not impenetrableat least on paper. "It's easy to say that the government isn't approving studies because they're politically incorrect," says Dr. Alan Leshner, former NIDA director. "The government may say yes."
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